With a record number of recalls as faulty birth control pills flood Canada’s marketplace — the most recent was this week — two respected physicians groups that represent more than 35,000 doctors nationwide are calling on Ottawa to fix the “debacle.” Stat.

Both the Society of Obstetricians and Gynaecologists of Canada and the College of Family Physicians of Canada have asked the federal health minister to quickly put in place a four-part plan that they say will protect the public and restore confidence in the system.

“We’re very concerned about the whole issue of quality now,” said Dr. Jennifer Blake, CEO of the Society of Obstetricians and Gynaecologists of Canada. “This is a problem that Canadians have not had to consider in the past. We’ve had a very reliable pipeline for contraception. …We have a safety problem now.”

.
More VideoService dog eases anxiety of veteran with PTSD
Service dog eases anxiety of veteran with PTSD

In letters to Health Canada, the two groups take aim at the companies that manufacture generic birth control pills and the pharmacists who switch out prescribed brand-name products and dispense generics without telling doctors or patients.

“We worry that people are coming into this field without the proper respect for women’s health and don’t seem to understand the nature of this beast,” said Blake. “Birth control has a completely different magnitude of risk attached.”

Since April, Health Canada has issued recalls for three generic oral contraceptives: Alysena from Apotex, and Freya-28 and Esme-28, which are made in India by Famy Care for U.S.-based Mylan Pharmaceuticals. More than 620,000 packages have been pulled from shelves in that time. About 430,000 of these packages had already been dispensed to Canadian women, according to IMS Brogan, a company that tracks health-care data.

The contraceptives were recalled because they contained too many placebos or “sugar” pills in place of active doses of medication — an error that can cause bleeding and unplanned pregnancy.

Mylan blamed a “packaging issue” and said it is investigating.

The company told Health Canada it was voluntarily recalling Esme-28, even though no extra placebos have yet been reported in packages, because it was “unable to definitively rule out the possibility (of error).”

Esme and Freya are both new to the Canadian market. Mylan launched Esme in October 2012. The latter was introduced in May 2013.

The Canadian Generic Pharmaceutical Association said it is “unfortunate” that the physicians are “incorrectly characterizing the reasons for the recent recall.”

Jeff Connell, CGPA’s vice-president of corporate affairs, said the problem boils down exclusively to a packaging error and is not reflective of the quality of generics.

“All generic drugs in Canada are approved by Health Canada and have been shown to be bioequivalent to the brand-name versions,” he said.

However, the physicians argue that it’s not that simple.

“This is something we’ve never seen before the appearance of generics,” said Dr. Amanda Hunt by telephone from Ottawa.

Hunt, a gynecologist/obstetrician, said she’s finding that patients who take generic birth control pills experience more “breakthrough bleeding.”

She generally writes “no substitutions” on birth control prescriptions to ensure that pharmacists don’t switch out the brand-name products she prescribes for cheaper generic versions.

The physicians groups want Health Canada to make it mandatory for pharmacists to disclose such pill switches to doctors and patients.

“It is entirely likely that most women and their doctors would not have known that they were taking the faulty Alysena pills,” the doctors’ letter stated. “Women must know what tablet they are taking. Women should have the option of a paying a fair fee for the brand-name drug if that is her preference.”

The doctors have also asked Health Canada to impose a regulation that generic drugs be identified only by their generic medical ingredients. They should not look or sound like an existing brand-name product, they say.

In a letter in June to the federal health minister, Blake wrote that when the society “initially called Health Canada to learn more about the faulty Apotex pills, marketed under the name Alysena, the staff person we spoke to responded, ‘Oh, you are calling about Alesse.’ ” (Alesse is a brand-name oral contraceptive.)

For patients, the similarity in names can lead to “potentially devastating confusion,” Blake said.

A package of 28 pills typically has one week of placebos to be taken at the end of the menstrual cycle. The sugar pills are meant to keep women in the habit of taking a daily dose and ensure they resume the active medicated doses at the right time. If a placebo is ingested too early in a cycle, the drug becomes less effective.

Some packages of Alysena 28 contained 14 sugar pills instead of seven. Packs of Freya-28 contained a single additional placebo in place of an active dose.

“Contemporary contraceptive tablets have an extremely low dose of hormone in each tablet, leaving little room for error in preparation and use,” the doctors’ letter states. “Canadian women and their partners have a right to expect proven levels of quality and effectiveness through the use of accepted tests.”

So exactly who is ensuring quality and effectiveness of the drugs sold in Canada but made overseas?

Health Canada said Canadian importers must provide evidence that the foreign sites are evaluated based on information from recognized regulatory authorities “for compliance with Canadian (Good Manufacturing Practices) standards.”

Famy Care, the India-based company that produces and packages Freya and Esme for Mylan, claims to export more than 150 million cycles of oral contraceptive pills a year.

Asked whether it had ever inspected Famy Care, Health Canada told the Star the Indian plant that makes Freya was inspected by the Netherlands and the one that makes Esme was inspected by Infarmed, a Portuguese regulatory body. (Canada relies on partners in Europe and Australia to help with inspections.)

Dr. Joel Lexchin, a professor of health policy at York University, said the birth control recalls point to a broader issue.

“For economic reasons, most of the drugs sold in North America are manufactured in part or total in low-cost countries, where there are thousands of plants,” he said.

“That doesn’t mean the companies want substandard products. But when economics is the bottom line, that is sometimes the consequence.”